Job Description
Aurum Biosciences is a pioneering biotechnology firm dedicated to developing breakthrough therapies for rare diseases. We are seeking a highly motivated Senior Clinical Research Associate (CRA) to join our growing clinical operations team.
In this role, you will be responsible for the end-to-end management of clinical trials, ensuring that our studies are conducted in compliance with Good Clinical Practice (GCP) and regulatory standards. You will work closely with cross-functional teams, including medical directors, data managers, and external investigators, to drive patient safety and data integrity.
If you are passionate about improving patient outcomes and have a keen eye for detail, we want to hear from you.
Responsibilities
- Manage and monitor clinical trial sites, ensuring adherence to study protocols and timelines.
- Conduct regular monitoring visits to assess patient safety, data quality, and investigator performance.
- Ensure full compliance with Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements.
- Prepare and submit accurate monitoring reports to Sponsor and Regulatory Affairs.
- Identify and resolve protocol deviations, safety issues, and site initiation challenges.
- Collaborate with the Data Management team to ensure accurate and timely data capture.
- Participate in internal training and external conferences to stay current on industry trends.
Qualifications
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field required; Master’s degree preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate in the pharmaceutical or biotechnology industry.
- Current GCP certification (e.g., RAC) is highly preferred.
- Strong knowledge of FDA regulations and EMA guidelines regarding clinical trials.
- Excellent written and verbal communication skills with the ability to build rapport with investigators.
- Proficiency in using electronic data capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical) and electronic source systems.